CMC Regulatory Services

In the field of CMC, our expert staff apply highly specialized skills to perform the tasks described below. They deliver regulatory affairs services of impeccable quality in support of customers inside and outside Japan across a broad range of activities.
Our CMC services range from support for drug substance filings and drug product approvals, to advice on GMP and consistency check.

Services Outline

Accreditation of Foreign Manufacturers

  • New Accreditation
  • Renewal of Accreditation
  • Addition of Accreditation Category


  • MF Registrations
  • MF ICC (In-Country Caretaker)
  • M2 Preparation
  • MF Review Response Management
  • GMP Compliance Reviews

Regulatory CMC consultation

  • Support of Marketing Authorization Application
    • Preparation of Application Form
    • Support preparation of attached documents

Performance Profile

Sales Component by Services (2019 – 2021)

* Please scroll horizontally to see.

Sales Component by Countries (2019 – 2021)

* Please scroll horizontally to see.